Senior Manager, Post-Market Pharmacovigilance (Remote - US)

Location: Remote within multiple US states

Company

hirify.global is a data-focused clinical research organization supporting pharmaceutical, biotech, and medical device companies with clinical trial data and regulatory submission challenges.

What you will do

• Lead global post-marketing case processing from intake through reporting and case closure.
• Develop and maintain pharmacovigilance workflows, procedures, work instructions, and quality review frameworks.
• Ensure compliance with Good Pharmacovigilance Practices, FDA requirements, company SOPs, and applicable regulatory guidance.
• Process cases independently, create and update deliverables, and manage safety database activities including MedDRA and WHO drug dictionary coding.
• Lead client meetings, resolve issues, negotiate with clients, and provide strategic subject-matter expertise.
• Manage projects from start to finish, identify process efficiencies, and mentor colleagues.

Requirements

• College degree in a scientific, medical, clinical, or related discipline; a master’s degree, PharmD, or PhD is preferred.
• At least 8 years of experience in drug safety, pharmacovigilance, or a similar field.
• Expertise with drug safety databases, scientific principles, pharmacovigilance quality systems, and post-marketing case processing.
• Proficiency in ICH E2A, E2B(R3), E2D, GVP, FDA, GCP, and 21 CFR Part 11 requirements.
• Understanding of clinical trial processes, pharmaceutical development, and the relationship between post-marketing pharmacovigilance and US REMS requirements.
• Strong communication, organization, problem-solving, collaboration, and Microsoft Office skills.

Nice to have

• Hands-on experience with clinical trials and pharmaceutical development.
• Familiarity with ISO 9001 and ISO 27001 standards.

Culture & Benefits

• Remote work within the United States.
• Collaborative and inclusive work environment.
• Opportunity to work with pharmaceutical, biotech, and medical device clients.
• Recognized Great Place to Work organization with a focus on employee retention.